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FDA Warns: ADHD Medications Linked to Painful, Long-Lasting Erections

Filed December 13th, 2013 Eric

Popular medications used to treat attention deficit hyperactivity disorder (ADHD) may cause prolonged and sometimes painful erections known as priapism.

The U.S. Food and Drug Administration (FDA) is warning the public about the dangers of methylphenidate products, one type of stimulant used to treat ADHD, noting that it can affect boys and men of any age. Based on a recent review of methylphenidate products, the agency updated drug labels and patient Medication Guides to include information about the rare but serious risk of priapism. The FDA warns that if not treated immediately, priapism can lead to permanent damage to the penis.

Priapism can occur in males of any age and happens when blood in the penis becomes trapped. When this occurs, an abnormally long-lasting and sometimes painful erection can occur. This group of drugs includes: Concerta, Daytrana, Focalin/Focalin XR, Metadate CD/Metadate ER, Methylin/Methylin ER, Quillivant XR, and Ritalin/Ritalin LA/Ritalin SR.

According to Reuters, the FDA’s review
 documented the problem in males 8
to 33 years of age who took drugs containing methylphenidate. The chemical is the active ingredient of Novartis AG’s Ritalin and Johnson & Johnson’s Concerta. Generic forms
of both drugs are also available.

The FDA said patients who develop erections lasting more than four hours should seek immediate medical attention to prevent any permanent damage to the penis, Reuters reported.

The ADHD drug, Strattera (atomoxetine) has also been associated with priapism in children, teens, and adults, the FDA said in its warning notice. This is not the only danger associated with taking Strattera. Use of Strattera – which is manufactured by Eli Lilli and Co. – has also been linked to a small increase in suicidal risks in some children and teens. Results from Strattera clinical studies with over 2200 child or teenage ADHD patients suggest that some children and teenagers may have a higher chance of having suicidal thoughts or actions, a warning on Strattera reads. Patients taking Strattera have also experienced problems passing urine, including trouble starting or keeping a urine stream, and not being able to fully empty the bladder.

While the amount of information the FDA has on the risk of painful erections is a bit limited, the agency believes priapism is more common in patients taking atomoxetine than in those taking methylphenidate products. At this time, the FDA does not know how often priapism occurs in patients taking either type of product.

Healthcare professionals are encouraged to talk to male patients and their caregivers to make sure they know the signs and symptoms of priapism and stress the need for immediate medical treatment should it occur. “Younger males, especially those who have not yet reached puberty, may not recognize the problem or may be embarrassed to tell anyone if it occurs,” the FDA said.

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